Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler® in Comparison with Diskus® and Turbohaler® Dry Powder Inhalers

Buttini, Francesca; Brambilla, G.; Copelli, Diego; Sisti, Viviana; Balducci, Anna; Bettini, Ruggero; Pasquali, Irene

doi:10.1089/jamp.2015.1220

Cited by 88 publications

(62 citation statements)

References 35 publications

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“…The NEXThaler device also delivers a so-called 'extrafine beclomethasone and formoterol aerosol' with particles micronized to a mass median aerodynamic diameter (MMAD) <1.5 μm. Chiesi claims to achieve higher lung deposition with better penetration into the small airways with such particles, compared to inhalation powders with a larger MMAD, due to lower oropharyngeal losses [88,89]. The magnesium stearate in the formulation facilitates effective dispersion of such small drug particles.…”

Section: 'Repair Actions' For Design Weaknesses Of Early Dpi Conceptsmentioning

confidence: 99%

Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

221

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Introduction: Early dry powder inhalers (DPIs) were designed for low drug doses in asthma and COPD therapy. Nearly all concepts contained carrier-based formulations and lacked efficient dispersion principles. Therefore, particle engineering and powder processing are increasingly applied to achieve acceptable lung deposition with these poorly designed inhalers. Areas covered: The consequences of the choices made for early DPI development with respect of efficacy, production costs and safety and the tremendous amount of energy put into understanding and controlling the dispersion performance of adhesive mixtures are discussed. Also newly developed particle manufacturing and powder formulation processes are presented as well as the challenges, objectives, and new tools available for future DPI design. Expert opinion: Improved inhaler design is desired to make DPIs for future applications cost-effective and safe. With an increasing interest in high dose drug delivery, vaccination and systemic delivery via the lungs, innovative formulation technologies alone may not be sufficient. Safety is served by increasing patient adherence to the therapy, minimizing the use of unnecessary excipients and designing simple and self-intuitive inhalers, which give good feedback to the patient about the inhalation maneuver. For some applications, like vaccination and delivery of hygroscopic formulations, disposable inhalers may be preferred. ARTICLE HISTORY

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Section: 'Repair Actions' For Design Weaknesses Of Early Dpi Conceptsmentioning

confidence: 99%

Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

221

View full text Add to dashboard Cite

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“…De Boer et al, 2015) the NEXThaler ® inhaler is a DPI (dry powder inhaler) device delivering an almost pressure-drop independent dose of BDP and FF. It has also been demonstrated that Foster ® NEXThaler ® emits a high fraction of fine (diameter < 5 μm) and extrafine (diameter < 2 μm) particles (Buttini et al, 2016) with high lung deposition efficiency and a more uniform deposition distribution . The special internal design and structure of the inhaler is considered to contribute to the above characteristics of the drug (Scichilone et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

Farkas

Lewis

Church

et al. 2017

International Journal of Pharmaceutics

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Link to publication record in Explore Bristol Research PDF-document This is the final published version of the article (version of record). It first appeared online via Elsevier at https://www.sciencedirect.com/science/article/pii/S0378517317309237 . Please refer to any applicable terms of use of the publisher. University of Bristol -Explore Bristol Research General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms A B S T R A C TThe breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler ® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers.The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study.Size distributions of Foster ® NEXThaler ® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5 s and 10 s breath-hold times.By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47-51%, while that of bronchodilator from 25-34% to 52-55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35-40% due to BAM. At the same time, predicted lung doses increased from about 20%-35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2-3% even for this profile when hygroscopic growth was taken into account.In conclusion, the NEXThaler ® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs.

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“…The DD from the Turbuhaler was similar, regardless if shaken or not. devices has been extensively studied [16,17]. For analogues to be approved in the European Union (EU), it is a prerequisite that the particle size distribution is similar to the originator product at three different flow rates: low, medium and high [18].…”

Section: Discussionmentioning

confidence: 99%